FreeStyle Libre 2 Approved by FDA for Children and Adults With Diabetes

Drug and device maker Abbott has won approval from the U.S. Food and Drug Administration (FDA) for its next generation FreeStyle Libre 2 iCGM system for adults and children ages 4 and older with diabetes.

While there are other iCGM (integrated continuous glucose monitor) systems currently on the market, including an older version of the same product made by Abbott, the continuous glucose monitoring sensor in the FreeStyle Libre 2 has the longest wearing time, at 14 days, notes the Abbott Park, Illinois–based company. The new platform also allows patients to see real-time blood sugar readings, and set optional alarms that will sound in real-time when glucose levels get too low or too high.

“The iCGM designation and the addition of alerts are significant improvements for patients with insulin-reated diabetes,” says Marc Breton, PhD, an associate professor of psychiatry and neurobehavioral sciences at the University of Virginia School of Medicine in Charlottesville, who researches blood glucose and insulin dynamics.

For the most part, though, the new product is an “incremental improvement over the previous version of the same sensor, the FreeStyle Libre,” Dr. Breton says.

Pricing for the FreeStyle Libre 2 will be the same as the previous version of this product, according to Abbott.

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